NCT07198126

Brief Summary

Pterygium, often called "surfer's eye," is a common eye condition in which a raised, fleshy growth of tissue extends from the white part of the eye onto the clear cornea. This growth can cause redness, irritation, blurred vision, and, in advanced cases, changes in the curvature of the cornea leading to distorted vision (astigmatism). The condition is more frequent in people exposed to sunlight, dust, and dry environments. The standard treatment for symptomatic pterygium is surgical removal. However, simple removal has a high chance of recurrence. To reduce this risk, surgeons commonly use a technique called conjunctival autograft transplantation, where a small piece of the patient's own conjunctiva is placed over the area after excision. This method not only lowers the recurrence rate but may also improve vision by reducing corneal irregularities. This study is designed to measure the changes in corneal curvature (keratometric readings) before and after pterygium excision with conjunctival autograft transplantation. By comparing preoperative and postoperative measurements, the study aims to determine how much this surgery improves corneal shape and reduces astigmatism. The hypothesis is that pterygium excision with conjunctival autograft transplantation will lead to a significant improvement in keratometric readings and reduce irregular astigmatism, thereby improving visual quality. This research will provide local evidence of the effectiveness of this procedure and help guide treatment strategies for patients suffering from pterygium-related visual problems.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 21, 2025

Last Update Submit

September 21, 2025

Conditions

Keywords

Pterygium excisionAstigmatism correctionConjunctival autograft transplantationRefractive error

Outcome Measures

Primary Outcomes (1)

  • Change in Keratometric Readings (K1 and K2)

    Keratometric readings, including the flat meridian (K1) and steep meridian (K2) of the anterior corneal surface, will be measured using a manual keratometer. The mean change in K-readings (measured in diopters) from baseline (pre-operative) to post-operative assessment will be calculated to evaluate corneal curvature improvement following pterygium excision with conjunctival autograft.

    Baseline (pre-operative) and 1 month post-operative.

Secondary Outcomes (1)

  • Change in Astigmatism

    Baseline (pre-operative) and 1 month post-operative.

Study Arms (1)

Group Pterygium Excision with Conjunctival Autograft

EXPERIMENTAL

Patients will undergo surgical excision of pterygium followed by conjunctival autograft transplantation. The autograft will be harvested from the superior bulbar conjunctiva and secured at the excision site using sutures.

Procedure: Pterygium Excision with Conjunctival Autograft

Interventions

Excision of primary Grade II or Grade III pterygium Conjunctival autograft harvested and transplanted at the excision site Graft secured with sutures

Group Pterygium Excision with Conjunctival Autograft

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults of either sex aged \>30 to 70 years.
  • Phakic eyes.
  • Primary pterygium, Grade II or Grade III (as per protocol grading).
  • Presence of corneal astigmatism on pre-operative assessment.
  • Scheduled for pterygium excision with conjunctival autograft transplantation at the study site.
  • Able to provide written informed consent and to attend the 1-month postoperative assessment.

You may not qualify if:

  • Pseudophakic or aphakic eyes.
  • Recurrent pterygium.
  • Prior keratoplasty or trabeculectomy in the study eye.
  • Keratoconus or other corneal pathologies that can independently induce astigmatism.
  • Lenticular astigmatism or significant lens pathology affecting refraction.
  • Eyes planned for simple pterygium excision without conjunctival autograft.
  • Any ocular condition or systemic illness judged likely to interfere with keratometric or refractive measurements, follow-up, or surgical safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mughal Eye Hospital Trust

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

PterygiumAstigmatismRefractive Errors

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2025

First Posted

September 30, 2025

Study Start

August 30, 2025

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations